FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different. The new § 820.10

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National Association of Boards of Pharmacy

OCTOBER 23, 2024

The exemption applies to “any … eligible trading partners, which … have successfully completed or made documented efforts to complete data connections with their immediate trading partners.” FDA took the right approach balancing the advancement of DSCSA implementation with risk of potential impacts to the flow of medicine.

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Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

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Express Pharma

APRIL 6, 2023

These experts can provide guidance on the specific licensing requirements for the startup’s products, help prepare and submit the necessary documentation, and ensure that the startup is following the correct procedures throughout the licensing process.

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FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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Syner-G

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

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National Association of Boards of Pharmacy

JULY 19, 2024

In this blog, we will explore questions around what dispensers are still responsible for within DSCSA, what they are actually exempt from, and how they can go about determining if they are exempt. Gathering transaction information for recalls at the package level. Conducting product verifications for suspect and illegitimate products.

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FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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Packaging Drug Development Documentation 64

National Association of Boards of Pharmacy

NOVEMBER 6, 2024

A Policy & Procedure (P&P) assessment is sent to you to help prepare and organize your documents for submission. Additionally, NABP offers educational resources such as free and low cost webinars on industry topics, blogs , newsletters from the states to their licensees, and weekly and biweekly email newsletters.

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Specialty Pharmacies Packaging Documentation 45

Syner-G

SEPTEMBER 20, 2023

If commercial, accessibility of cGMP API for proof of concept (POC) studies is much more possible in bulk in the open market, and may already be packaged in a suitable dosage form or strength for human trials. Repurposed commercial drugs also provide the advantage of having many patient years of reported safety data.

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Pharmacy Joe

OCTOBER 25, 2023

Subscribe on iTunes , Android , or Stitcher If you navigate to the page on the website for the Institute for Safe Medication Practices that once hosted the document titled “Oral Dosage Forms That Should Not Be Crushed” you will instead find a notice that the list has been removed from the ISMP website.

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epicur

AUGUST 8, 2023

Some of the biggest changes that GFI #256 brings include: Increased documentation for patient-specific prescriptions Limitations to available 503A office-stock drugs Although veterinary professionals were aware of the impending changes with GFI for months, many have been left scrambling since it went into effect in April. Read our blog!

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Compounding Documentation Compounding Pharmacies Packaging 52

GMPSOP

JULY 14, 2023

Equipment cleaning validation protocol was not discussed intensely in this article which was covered elsewhere in this blog. Additional documents included each month. Additional documents included each month. c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in 211.180 and 211.182.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Board Vitals - Pharmacist

NOVEMBER 8, 2022

Once clinicians have translated their research and skills into practice, they need to learn how to measure, quantify and document the outcomes data. appeared first on BoardVitals Blog. Developing and Evaluating Your EBM Educational Modules: BoardVitals Can Be Your Partner.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Still, the document provides some guidance (naturally) as to materials required to submit a successful meeting request. And the Guidance may be used as leverage to secure action from FDA on a meeting request. The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

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FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g., CMS’ final regulation expansively defines a “misclassification” to include not only misclassifying the drug category (e.g., Remarkably, manufacturers may not dispute a CMS notification.

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Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating.

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RX Note

FEBRUARY 23, 2023

Introduction The purpose of this table of contents is to enable you to know clearly which topics are available in the blog, hence easing your learning process. Wistify.app - Another method to quickly convert spreadsheet to mobile application Thoughts Blogging - Blogger or WordPress? Ancora imparo: I am still learning.

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FDA Law Blog: Biosimilars

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.

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FDA Law Blog: Biosimilars

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). However, given the similarities between these draft guidance documents, similar comments may be expected.

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